The invention relates generally to medical devices, and more particularly to medical systems, medicament delivery devices and methods for delivering a medicament into a body of a patient and outputting an electronic signal in response to such delivery.
Self-administered medicament delivery devices, such as, for example pre-filled medical injectors, inhalers, transdermal delivery devices and the like are often used as a part of a patient's medication regimen. For example, known self-administered medicament delivery devices can be used as a part of a patient's emergency care regimen. Emergency care regimens can include, for example, using an auto-injector to rapidly self-administer a medicament in response to an allergic reaction or for the treatment of other emergency conditions (e.g., nerve-agent poisoning on the battlefield). Known self-administered medicament delivery devices can also be used as a part of a patient's chronic care regimen. Chronic care regimens can include, for example, using a pen injector to self-administer a medicament according to a prescribed plan. Examples of chronic care regimens can include, for example, the injection of insulin, the injection of human growth hormone (HGH), erythropoiesis-stimulating agents (ESA), DeMab, Interferons and other chronic therapies, or the like. Furthermore, self-administered medicament delivery devices can also be used for preventive/prophylactic therapies. Examples of preventive/prophylactic therapies include certain vaccines, such as an influenza vaccine.
In the pharmaceutical industry, it can be important to understand patient compliance with self-administered medicament delivery devices. Patient compliance can include any measure of a patient's conformance to a particular therapeutic drug delivery regimen or other indication as mandated by a health care provider or pharmaceutical manufacturer. More particularly, patient compliance measures can include the location where the device was activated, time of day, dose regimen, dosage and route of administration, frequency of device usage, functionality of the device once used, expiration date of the device, device status, medicament status, and any adverse event experienced by the user following the use of the device. Patient compliance can also include providing communication to the patient regarding their therapy (e.g., a notification of when to take their medication, etc.). Understanding patient compliance with medicament delivery devices can enhance the ability of a health care provider to effectively manage a patient's medication regimen, which can lead to improved patient outcomes. Patient compliance data can also be used to inform the manufacturer of the device about potential issues with the device (e.g., data demonstrating poor compliance with a particular device may trigger a manufacturer to investigate the cause of poor compliance and/or change the design or functionality of the device to improve patient care and outcome), alert emergency contacts (including family members, patient guardians, and individuals with Power of Attorney privileges), and aid the patient with adhering to their prescribed therapy. Increasing patient compliance can also generate considerable cost savings for health care providers, pharmaceutical benefits managers (PBM), specialty pharmacies, clinical trial administrators, insurance companies and/or payors.
Ensuring patient compliance with some known medicament delivery devices can be problematic. For example, some known medicament delivery devices (e.g., emergency care devices, as described above and/or chronic care devices) can be bulky and conspicuous, which can make carrying them inconvenient and undesirable. Accordingly, the patient may not carry the medicament delivery device at all times, resulting in the failure to use the medicament delivery device as prescribed.
Similarly, to actuate some known medicament delivery devices, the user may be required to execute a series of operations. For example, to actuate some known auto-injectors, the user must remove a protective cap, remove a locking device, place the auto-injector in a proper position against the body and then press a button to actuate the auto-injector. Failure to complete these operations properly can result in an incomplete injection and/or injection into an undesired location of the body.
The likelihood of improper use of known medicament delivery devices can be compounded by the nature of the user and/or the circumstances under which such devices are used. For example, many users are not trained medical professionals and may have never been trained in the operation of such devices. Moreover, in certain situations, the user may not be the patient, and may therefore have no experience with the medicament delivery device. Similarly, because some known medicament delivery devices are configured to be used relatively infrequently in response to an allergic reaction or the like, even those users familiar with the device and/or who have been trained may not be well practiced at operating the device. Finally, such devices often can be used during an emergency situation, during which even experienced and/or trained users may be subject to confusion, panic and/or the physiological effects of the condition requiring treatment.
Monitoring the patient's compliance with known medicament delivery devices can also be problematic. For example, some known medicament delivery systems include a medicament delivery device and an electronic system to assist the user in setting the proper dosage and/or maintaining a compliance log. Such known medicament delivery systems and the accompanying electronic systems can be large and therefore not conveniently carried by the user. Such known medicament delivery systems and the accompanying electronic systems can also be complicated to use and/or expensive to manufacture.
Thus, a need exists for medicament delivery systems and/or devices that can provide compliance information associated with the use of the device. Moreover, a need exists for medicament delivery systems and/or devices that can communicate electronically with other communications devices.